Acute Iliofemoral Deep Vein Thrombosis
Conditions
Interventions
Product Name: Microplasmin
Product Code: M-PLA-P08-POOL-40
Pharmaceutical Form: Solution for infusion
Current Sponsor code: M-PLA-P08-P00L-40
Concentration unit: mg/ml milligram(s)/millilitre
Concentr
Sponsors
ThromboGenics Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient must meet all of the following criteria, in order to be included in the study: a) Patient is at least 18 years old. b) Patient has clinical manifestations (i.e. symptoms and/or signs) of acute DVT of the lower extremity. c) Duration of leg symptoms 2.75 mm). f) Women of child-bearing potential must have a negative pregnancy test prior to enrollment and be using a reliable form of contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: If the patient has any of the following criteria, they must be excluded from the study: a) Isolated calf or popliteal vein DVT, based on duplex ultrasound. b) Thrombus involving the inferior vena cava (IVC). c) Proximal (e.g. cranial) aspect of thrombus cannot be adequately assessed to level of the iliac veins or inferior vena cava, based on duplex ultrasound. d) Cannot traverse the target vessel segment with guidewire. e) Symptomatic pulmonary embolism is present at time of presentation. f) Documented history of prior DVT in target extremity g) History of anticoagulants administered for greater to or equal to 30 days for undocumented/ unclear reason (e.g. for other than presence of mechanical cardiac valve, atrial fibrillation, etc.). h) Documented history of thrombophilic disorder, with diagnosis established via previous objective testing (e.g. familial screening for thrombophilia). i) Cannot receive standard secondary prevention pharmacotherapy [i.e. heparin or LMWH and vitamin K antagonists (VKA)] due to contraindications to anticoagulation [e.g. known bleeding diathesis, thrombocytopenia (platelets 2.0 mg/dL). t) Unwilling or unable to provide informed consent, or return for required follow-up evaluations. u) Previous participation in this study. v) Patient has participated in another investigational study within the previous 30 days. w) Pregnancy, nursing, positive or indeterminate pregnancy test, women of child-bearing potential not using an adequate form of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: None ;Main Objective: The primary purpose of this study is to evaluate the safety and efficacy of microplasmin administration using the Trellis-8 Infusion System in patients with acute iliofemoral DVT. The primary objectives of this study are to: • Assess the degree of thrombus removal and flow restoration attained following administration of microplasmin using Trellis-8 Infusion System, via venography. • Assess patency of treated veins via duplex ultrasonography. • Examine symptom improvement for patients receiving index procedure (treatment) plus anticoagulation post index procedure. • Examine total thrombolytic dose and duration of thrombolytic therapy during index procedure. • Assess coagulation parameters and the incidence of bleeding and other adverse events pre, peri and post index procedure. ;Primary end point(s): Primary Endpoint/Efficacy Parameter: Treatment Success Target vessel segment treated using microplasmin administered via the Trellis-8 Infusion System demonstrates less than or equal to 25% residual thrombus AND flow is present following administration of microplasmin via the Trellis-8 Infusion System, before any adjunctive manoeuvres to address underlying disease or residual thrombus. This will be assessed during the interventional procedure, based on venography. | — |
Countries
Ireland
Outcome results
None listed